Unipolar DepressionPhase 2ImproveNCT02822443
Improve: Integrating Emotion Focused Components Into Psychological Therapy
A Phase 2 study testing Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT) and Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR) in people with Unipolar Depression and Anxiety Disorder, run by University of Bern at 1 site in Switzerland.
Trial summary
The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on differential effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression, Anxiety Disorder, Adjustment Disorder
- What is being tested?
- Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT) and Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder, Anxiety Disorder or Adjustment Disorder according to DSM-IV as main diagnosis
- Minimum age of 18 years
- Mastery of the German language for being able to undergo a psychotherapy in German
- Written informed consent to participate voluntary in the study
Who cannot join
- Acute suicidality or immediate threats of self-harm
- Diagnosis or history of a psychotic disorder
- Mood incongruent psychotic symptoms
- Bipolar disorder
- Comorbid chronic organic disorder
- Substance use disorder as a main diagnosis
- Indication for a residential treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Integrating Emotion Focused Components Into Psychological Therapy
The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on differential effects. Moreover, the mechanisms of change of both conditions are investigated.
Read the detailed description
Background:
"General Psychotherapy" postulates an ongoing process of including all interventions and concepts relevant for a domain, be they from other approaches to psychotherapy or concepts from basic science. "Psychological Therapy" (PT) is a therapeutic approach largely corresponding to the ideas of General Psychotherapy. It draws mainly on empirically validated interventions from Cognitive Behavior Therapy (CBT) and is based on concepts with a strong basis in academic psychology and neighboring fields. PT is based on explicit individual case conceptualization, reference to general therapeutic factors, and an explicit prescriptive concept for building and maintaining the therapeutic relationship. However the range of emotion-related interventions commonly used in PT is limited when compared with an approach like Emotion Focused Therapy (EFT). EFT appears thus as a suitable complement and enrichment to PT as commonly practiced. However, effects of integrating EFT-based interventions in a way that is close to common integrative practice have not yet been studied.
Objective:
To compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of EFT components and TAU with focus on self-regulation (SR).
Methods:
In Switzerland, a randomized-controlled trail will be carried out in secondary care, comparing the efficacy of TAU - EFT and TAU - SR for adults with major depressive disorder, anxiety disorder or adjustment disorder. Respondents will be followed until 36 months after end of therapy (measures will be taken at baseline, after 8 and after 16 weeks, at the end of therapy after 25 weeks, 6 months, 12 months and 36 months follow-up).
- Conditions
- Unipolar Depression, Anxiety Disorder, Adjustment Disorder
- Being tested
- Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT), Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)Behavioural
25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.
Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)Behavioural
25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions
| Study group | Role | What they receive |
|---|---|---|
| TAU - EFT | Experimental | This arm integrates emotion focused components (EFT; Greenberg, 2010) into psychological therapy (PT) as treatment-as-usual (TAU), aiming at clarifying and transforming maladaptive emotions. 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions. Receives: Behavioral: Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT) |
| TAU - SR | Experimental | This arm focuses on the training of self-regulation strategies (SR; Carver \& Scheier, 2000) in the context of psychological therapy (PT) as treatment-as-usual (TAU). 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions. Receives: Behavioral: Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000)
Measured: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Change from baseline in depressive symptoms measured by the Beck Depression Inventory (BDI-II; Hautzinger et al., 2006)
Measured: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Change from baseline in anxiety symptoms measured by the Beck Anxiety Inventory (BAI; Ehlers & Margraf, 2007)
Measured: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Secondary outcomes (26)
Severity of panic disorder and agoraphobia with the Panic and Agoraphobia Scale (PAS; Bandelow, 1997)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of social phobia measured by the Social Phobia Scale SPS; Stangier et al., 1999)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of social interaction anxiety measured by the Social Interaction Anxiety Scale (SIAS; Stangier et al., 1999)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of anxiety symptoms measured by the Questionnaire for General Anxiety Disorder (GAD-7; Spitzer et al., 2006)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Psychological well-being measured with the WHO Well-Being Index (WHO-5; Henkel et al., 2004)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Health-related quality of life measured with the Short Form Healthy Survey (SF-12; Gandek et al., 1998)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Motivational schemata measured by the Questionnaire for Analysis of Motivational Schemata (FAMOS; grosse Holtforth & Grawe, 2000)
Measured: Baseline, end of therapy after 25 weeks
Motivational incongruence measured by the Incongruence Questionnaire (K-INK; grosse Holtforth et al., 2003)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Interpersonal problems measured by the Inventory of Interpersonal Problems (IIP-32; Thomas et al., 2011)
Measured: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Personality structure measured by the Operationalized Psychodynamic Diagnosis Structure Questionnaire (OPD-SFK; Ehrenthal et al., 2012)
Measured: Baseline, end of therapy after 25 weeks
Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013)
Measured: Baseline
Ambivalence over emotional expressiveness measured by the Ambivalence over the Expression of Emotion Scale (AVEX; Trachsel et al., 2010)
Measured: Baseline, end of therapy after 25 weeks
Emotional competency measured by the Questionnaire for the self-assessment of emotional competencies (SEK-27; Berking & Znoj, 2008)
Measured: Baseline, end of therapy after 25 weeks
Generalized expectancies for negative mood regulation measured by the Negative Mood Regulation Scale (NMR-SF; Pfeiffer et al., 2013)
Measured: Baseline, end of therapy after 25 weeks
Psychological flexibility measured by the Acceptance and Action Questionnaire (Fragebogen zu Akzeptanz und Handeln; FAH-II; Gloster et al., 2013)
Measured: Baseline, end of therapy after 25 weeks
General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999)
Measured: Baseline, end of therapy after 25 weeks
Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005)
Measured: Baseline
Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006)
Measured: Baseline
Client satisfaction measured by the Brief Global Measure of Client Satisfaction (ZUF-8; Schmidt & Wittmann, 2002)
Measured: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
External assessment of interpersonal personality measured by the Impact Message Inventory (IMI-R; Caspar et al. 2002)
Measured: Baseline, end of therapy after 25 weeks
External assessment of resources measured by the Bernese Inventory of Resources (REF-F and REF-T; Tröske, 2000)
Measured: Baseline, end of therapy after 25 weeks
External assessment of positive interpersonal qualities measured by the Inventory of Interpersonal Strengths (IIS; Hatcher & Rogers, 2012)
Measured: Baseline, end of therapy after 25 weeks
Goal attainment measured by the Goal Attainment Scaling (GAS; Kirusek, 1994)
Measured: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Regular quality monitoring with the Bern Post Session Report, Patient and Therapist Version (BPSR-P/T; Flückiger et al. 2010)
Measured: Weekly until 25 weeks
Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001)
Measured: Weekly until 25 weeks
Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013)
Measured: Baseline, end of therapy after 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franz Caspar, Prof. PhD, Principal investigator, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822443
- Sponsor's protocol ID
- SNF100019_159425 /1
- Acronym
- Improve
- Status last verified
- Sep 2019
- First submitted
- 22 Jun 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Babl A, Grosse Holtforth M, Heer S, Lin M, Stahli A, Holstein D, Belz M, Egenolf Y, Frischknecht E, Ramseyer F, Regli D, Schmied E, Fluckiger C, Brodbeck J, Berger T, Caspar F. Psychotherapy integration under scrutiny: investigating the impact of integrating emotion-focused components into a CBT-based approach: a study protocol of a randomized controlled trial. BMC Psychiatry. 2016 Nov 24;16(1):423. doi: 10.1186/s12888-016-1136-7.
PubMed 27881113
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Integrating Emotion Focused Components Into Psychological Therapy
- ClinicalTrials.gov ID
- NCT02822443
- Acronym / sponsor ID
- Improve / SNF100019_159425 /1
- Conditions
- Unipolar Depression, Anxiety Disorder, Adjustment Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on differential effects. Moreover, the mechanisms of change of both conditions are investigated.
Detailed description
Background:
"General Psychotherapy" postulates an ongoing process of including all interventions and concepts relevant for a domain, be they from other approaches to psychotherapy or concepts from basic science. "Psychological Therapy" (PT) is a therapeutic approach largely corresponding to the ideas of General Psychotherapy. It draws mainly on empirically validated interventions from Cognitive Behavior Therapy (CBT) and is based on concepts with a strong basis in academic psychology and neighboring fields. PT is based on explicit individual case conceptualization, reference to general therapeutic factors, and an explicit prescriptive concept for building and maintaining the therapeutic relationship. However the range of emotion-related interventions commonly used in PT is limited when compared with an approach like Emotion Focused Therapy (EFT). EFT appears thus as a suitable complement and enrichment to PT as commonly practiced. However, effects of integrating EFT-based interventions in a way that is close to common integrative practice have not yet been studied.
Objective:
To compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of EFT components and TAU with focus on self-regulation (SR).
Methods:
In Switzerland, a randomized-controlled trail will be carried out in secondary care, comparing the efficacy of TAU - EFT and TAU - SR for adults with major depressive disorder, anxiety disorder or adjustment disorder. Respondents will be followed until 36 months after end of therapy (measures will be taken at baseline, after 8 and after 16 weeks, at the end of therapy after 25 weeks, 6 months, 12 months and 36 months follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU - EFT | Experimental | Behavioral: Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)This arm integrates emotion focused components (EFT; Greenberg, 2010) into psychological therapy (PT) as treatment-as-usual (TAU), aiming at clarifying and transforming maladaptive emotions. 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions. |
| TAU - SR | Experimental | Behavioral: Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)This arm focuses on the training of self-regulation strategies (SR; Carver \& Scheier, 2000) in the context of psychological therapy (PT) as treatment-as-usual (TAU). 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major Depressive Disorder, Anxiety Disorder or Adjustment Disorder according to DSM-IV as main diagnosis
- Minimum age of 18 years
- Mastery of the German language for being able to undergo a psychotherapy in German
- Written informed consent to participate voluntary in the study
Key exclusion criteria (7 listed)
- Acute suicidality or immediate threats of self-harm
- Diagnosis or history of a psychotic disorder
- Mood incongruent psychotic symptoms
- Bipolar disorder
- Comorbid chronic organic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions. | Behavioural | TAU - EFT |
| Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions | Behavioural | TAU - SR |
Primary outcome
Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000)
Time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Change from baseline in depressive symptoms measured by the Beck Depression Inventory (BDI-II; Hautzinger et al., 2006)
Time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Change from baseline in anxiety symptoms measured by the Beck Anxiety Inventory (BAI; Ehlers & Margraf, 2007)
Time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
26 secondary outcomes
Severity of panic disorder and agoraphobia with the Panic and Agoraphobia Scale (PAS; Bandelow, 1997)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of social phobia measured by the Social Phobia Scale SPS; Stangier et al., 1999)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of social interaction anxiety measured by the Social Interaction Anxiety Scale (SIAS; Stangier et al., 1999)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Severity of anxiety symptoms measured by the Questionnaire for General Anxiety Disorder (GAD-7; Spitzer et al., 2006)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Psychological well-being measured with the WHO Well-Being Index (WHO-5; Henkel et al., 2004)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Health-related quality of life measured with the Short Form Healthy Survey (SF-12; Gandek et al., 1998)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Motivational schemata measured by the Questionnaire for Analysis of Motivational Schemata (FAMOS; grosse Holtforth & Grawe, 2000)
Time frame: Baseline, end of therapy after 25 weeks
Motivational incongruence measured by the Incongruence Questionnaire (K-INK; grosse Holtforth et al., 2003)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Interpersonal problems measured by the Inventory of Interpersonal Problems (IIP-32; Thomas et al., 2011)
Time frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Personality structure measured by the Operationalized Psychodynamic Diagnosis Structure Questionnaire (OPD-SFK; Ehrenthal et al., 2012)
Time frame: Baseline, end of therapy after 25 weeks
Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013)
Time frame: Baseline
Ambivalence over emotional expressiveness measured by the Ambivalence over the Expression of Emotion Scale (AVEX; Trachsel et al., 2010)
Time frame: Baseline, end of therapy after 25 weeks
Emotional competency measured by the Questionnaire for the self-assessment of emotional competencies (SEK-27; Berking & Znoj, 2008)
Time frame: Baseline, end of therapy after 25 weeks
Generalized expectancies for negative mood regulation measured by the Negative Mood Regulation Scale (NMR-SF; Pfeiffer et al., 2013)
Time frame: Baseline, end of therapy after 25 weeks
Psychological flexibility measured by the Acceptance and Action Questionnaire (Fragebogen zu Akzeptanz und Handeln; FAH-II; Gloster et al., 2013)
Time frame: Baseline, end of therapy after 25 weeks
General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999)
Time frame: Baseline, end of therapy after 25 weeks
Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005)
Time frame: Baseline
Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006)
Time frame: Baseline
Client satisfaction measured by the Brief Global Measure of Client Satisfaction (ZUF-8; Schmidt & Wittmann, 2002)
Time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
External assessment of interpersonal personality measured by the Impact Message Inventory (IMI-R; Caspar et al. 2002)
Time frame: Baseline, end of therapy after 25 weeks
External assessment of resources measured by the Bernese Inventory of Resources (REF-F and REF-T; Tröske, 2000)
Time frame: Baseline, end of therapy after 25 weeks
External assessment of positive interpersonal qualities measured by the Inventory of Interpersonal Strengths (IIS; Hatcher & Rogers, 2012)
Time frame: Baseline, end of therapy after 25 weeks
Goal attainment measured by the Goal Attainment Scaling (GAS; Kirusek, 1994)
Time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up
Regular quality monitoring with the Bern Post Session Report, Patient and Therapist Version (BPSR-P/T; Flückiger et al. 2010)
Time frame: Weekly until 25 weeks
Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001)
Time frame: Weekly until 25 weeks
Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013)
Time frame: Baseline, end of therapy after 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 27881113Babl A, Grosse Holtforth M, Heer S, Lin M, Stahli A, Holstein D, Belz M, Egenolf Y, Frischknecht E, Ramseyer F, Regli D, Schmied E, Fluckiger C, Brodbeck J, Berger T, Caspar F. Psychotherapy integration under scrutiny: investigating the impact of integrating emotion-focused components into a CBT-based approach: a study protocol of a randomized controlled trial. BMC Psychiatry. 2016 Nov 24;16(1):423. doi: 10.1186/s12888-016-1136-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Caspar, Prof. PhD principal investigator
University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT) and Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR) in people with Unipolar Depression and Anxiety Disorder, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000) (time frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.